Manufacturing Documentation Specialist

4 days ago

Carlow, Ireland beBeeProcess Full time €55,000 - €70,000
Key Responsibilities:
  • Support operational excellence through meticulous documentation generation, thorough equipment and process investigations related to non-compliance activities and completion of quality notifications.
  • Collaborate with the MES development team on technical aspects of MES functionality and serve as MES subject matter expert within IPT
  • Be a document management expert; this will include document review, approval, and document workflow expedition.
  • Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so.
  • Documents will include SOP's, SWI's, training documents, and change controls.
  • Ensure smooth operation activities through timely documentation generation, filing, tracking, auditing, and efficient maintenance of all associated databases including the maintenance, auditing, and archiving of the process documentation system.
  • Support batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
  • Raise Corrective Actions and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.

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